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HPTN 034
HIV Incidence and Participant Retention Protocol, Pune, India

Protocol Status: Participants Off Study & Primary Analysis Complete

Study Summary

Study Purpose: To ensure that the HPTU in Pune, India, is optimized for the initiation, enrollment, and retention of participants for future HPTN HIV prevention trials.

Study Design: Prospective cohort study with a 12-month accrual period and 12 months of follow-up for each participant. Note: Based on an HPTN SMC recommendation, the study accrual period was extended by 5.5 months. Note: LOA # 1 increased participant follow-up by 5.5 months (total of 17.5 months).

Study Population: HIV-uninfected non-sex worker women and HIV-discordant heterosexual couples attending STD clinics in Pune, India.

Study Size: 1200 participants total (400 adult HIV-uninfected non-sex worker women attending STD clinics and 400 HIV discordant heterosexual couples from Pune, India.) Note: LOA # 1 increased the size of the study population from 1200 to 1600 (540 adult HIV-uninfected non-sex worker women attending STD clinics and 530 HIV discordant heterosexual couples).

Study Duration: Accrual will require 12 months and participants will complete one year of follow-up. Therefore, the study should be completed within approximately 24 months. Note: Based on an HPTN SMC recommendation, the study accrual period was extended by 5.5 months, thus the study should be completed within approximately 30 months. Note: LOA # 1 increased participant follow-up by 5.5 months (total of 17.5 months) and thus the study should be completed within approximately 36 months. Note: Based on the recommendations of the HPTN SMC, enrollement of HIV-negative, high-risk woman ended on November 5, 2004 and enrollment of HIV-serodiscordant couples ended on November 30, 2004. All HIV-negative, high-risk women enrolled prior to February 1, 2004 will be terminated at their regularly scheduled visits between November 2004 and January 2005. All other study participants will be followed until August 31, 2005.

Treatment Regimen: None. However STD and HIV pre-test, risk reduction, and post-test counseling will be provided at each testing timepoint; STD treatment also will be provided.

Primary Objectives: To determine the current incidence of HIV among a cohort of 400 newly identified high-risk, women in Pune, as well as among 400 HIV-uninfected partners of HIV-infected persons. Note: LOA # 1 increased the size of the study population from 1200 to 1600 (540 adult HIV-uninfected non-sex worker women attending STD clinics and 530 HIV discordant heterosexual couples). To determine the retention rate in high-risk women, as well as HIV discordant couples, among a target population eligible for screening for upcoming HPTN 035 and 052 trials.

Secondary Objectives: To assess risk factors for HIV and other STDs. To identify and address potential barriers to participation and high- level retention (>95% 1 year retention) for the upcoming HPTN clinical trials.

Protocol Co-Chair: Sanjay Mehendale get info

Protocol Chair: Robert C. Bollinger get info

CORE Protocol Specialist: Theresa Gamble get info

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